Kidney Transplant RejectionPhase 2NCT06126380
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
A Phase 2 study testing AT-1501 and Tacrolimus in people with Kidney Transplant Rejection, run by Eledon Pharmaceuticals at 43 sites in 8 countries.
Trial summary
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- AT-1501 and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 43 sitesin 8 countries
- Study dates
- 25 Oct 2023to Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successfully completed qualifying Parent study, where entry into the OLE was offered;
- Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent;
- Agree not to participate in another interventional study while on treatment;
- If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline, through 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6.
- If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.
Who cannot join
- Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator;
- Met any of the stopping criteria or discontinued study drug in the Parent study;
- Pregnant or breastfeeding.
Trial locations and contacts
43 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
43 sites in 8 countries
United States26 sites
Emory University Hospital
Atlanta, Georgia, 30322
Augusta University
Augusta, Georgia, 30912
John Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
UT Southwestern
Dallas, Texas, 75235
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
University of Pittsburgh Medical Center
Harrisburg, Pennsylvania, 17104
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California Los Angeles
Los Angeles, California, 90024
Keck School of Medicine of USC
Los Angeles, California, 90033
Loyola University Medical Center
Maywood, Illinois, 60153
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Tulane Medical Center
New Orleans, Louisiana, 70112
New York University Langone Health - Tisch Hospital
New York, New York, 10016
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of California, Irvine Medical Center
Orange, California, 92868
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55907
University of California, Davis Medical Center
Sacramento, California, 95817
Jacobs Medical Center at UC San Diego Health
San Diego, California, 92037
Washington University in St. Louis
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Spain5 sites
Hospital del Mar - Parc de Salut Mar
Barcelona, 08003
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinical de Barcelona
Barcelona, 08036
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Germans Trias i Pujol
Barcelona, 08916
France4 sites
Groupe Hospitalier Pellegrin
Bordeaux
CHU Grenoble-Alpes - Hopital Nord Michallon
Grenoble, 38700
Centre Hospitalier Universitaire Dupuytren
Limoges, 07042
CHU de Toulouse - Hopital de Rangueil
Toulouse, 31400
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Fiona Stanley Hospital
Perth, Western Australia, 6150
Brazil2 sites
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo, 04038-002
Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo, 05403-010
Canada2 sites
McGill University Health Care Centre
Montreal, Quebec, H4A 3J1
St. Paul's Hospital
Vancouver, British Columbia, V6Z IY6
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
Oxford, OX3 9DU
About this study
Official title: AT-1501-K209: BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
Read the detailed description
This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in the preservation of allograft function after kidney transplantation.
The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study.
Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.
- Conditions
- Kidney Transplant Rejection
- Being tested
- AT-1501, Tacrolimus
- Keywords
- Kidney Transplant, AT-1501, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, monoclonal antibody, renal, transplant, ESRD, tegoprubart
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-1501Drug
Also called Tegoprubart
AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
TacrolimusDrug
Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent
| Study group | Role | What they receive |
|---|---|---|
| AT-1501 | Experimental | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent Receives: Drug: AT-1501 |
| Tacrolimus | Active comparator | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability - Incidence of Treatment Emergent Adverse Events
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Measured: Assessed from date of enrollment through Month 48
Safety and Tolerability - Kidney Transplant Medication Side Effects
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.
Measured: Assessed from date of enrollment through Month 48
Secondary outcomes (4)
The proportion of patient and graft survival at 12, 24, 36, and 48 months
A participant is considered to have graft functional impairment if they have an eGFR <60 mL/min/1.73m^2.
Measured: Assessed from date of enrollment through Month 48
The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months
A participant is considered to have graft functional impairment if they have an eGFR <60 mL/min/1.73m^2.
Measured: Assessed from date of enrollment through Month 48
Proportion of participants with BPAR at 12, 24, 36, and 48 months
The Proportion of participants with BPAR at 12, 24, 36, and 48 months.
Measured: Assessed from date of enrollment through Month 48
Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months
The Proportion of participants with composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months.
Measured: Assessed from date of enrollment through Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start25 Oct 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eledon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126380
- Sponsor's protocol ID
- AT-1501-K209
- Other IDs
- EU CTR, UTN
- Status last verified
- Mar 2025
- First submitted
- 6 Nov 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No